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Schedules to Medicines and Related Substances Act Updated

May 24, 2019

Department of Health

24 May 2019

Schedules to the Medicines and Related Substances Act have been updated.

The health department published the amendments in Government Gazette 42477.

The amendments follow recommendations made by the South African Health Regulatory Authority.

Section 22A(2) empowers the health minister to prescribe scheduled substances.

The schedules list substances that are excluded when specifically packed, labelled, sold and used for industrial purposes and analytical laboratory purposes.

They also outline who can prescribe and supply such substances and medicines.

Schedule 1 deals with Fexofenadine; Schedule 2 with Budesonide to treat allergic rhinitis and Fusidic acid when intended for topical application; Schedule 3 with Budesonide; schedule 4 with a number of medicines including Baricitinib, Belimumab, Cobicistat, Venetoclax and cannabidiol; Schedule 6 with Carfentanil when intended for veterinary use and Schedule 7 with a number of medicines including AB –CHMINACA and AB –PINACA plus the removal of cannabidiol.

Cannabidiol can now be obtained on prescription as a Schedule 4 drug.

The amendments to the schedules came into effect on the date of publication.

Meanwhile, in Notice 756, the department has excluded preparations containing cannabidiol that contain a maximum daily dose of 20 mg cannabidiol for general health enhancement, health maintenance or relief of minor symptoms and consist of processed products made from cannabis raw plant material and processed products which contain not more than 0,001 % of tetrahydrocannabinol and not more than 0,0075 % total cannabidiol from the schedules.

The exemption, now in force, applies for 12 months.